{
"info": {
"nct_id": "NCT06353191",
"official_title": "Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity",
"inclusion_criteria": "* 18 years of age or older\n* Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy\n* One of the following:\n\n * Diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment\n * Completed chemotherapy with no cardiotoxicity at least two years post treatment\n * Patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity\n* An understanding of the protocol and its requirements, risks, and discomforts\n* The ability and willingness to sign an informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "- Inability on the part of the patient to understand the informed consent or be compliant with the protocol",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* 18 years of age or older",
"criterions": [
{
"exact_snippets": "18 years of age or older",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "18 years of age or older",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy",
"criterions": [
{
"exact_snippets": "Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy",
"criterion": "treatment for malignancy",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"chemotherapy",
"oral",
"parenteral therapy",
"immunotherapy"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy",
"criterion": "treatment for malignancy",
"requirement": {
"requirement_type": "treatment type",
"expected_value": [
"chemotherapy",
"oral",
"parenteral therapy",
"immunotherapy"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment",
"criterions": [
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; cardiomyopathy",
"criterion": "cardiomyopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... symptomatic heart failure",
"criterion": "symptomatic heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... asymptomatic reduced systolic function",
"criterion": "asymptomatic reduced systolic function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... acute coronary syndrome",
"criterion": "acute coronary syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... critical limb ischemia",
"criterion": "critical limb ischemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... cardiac arrhythmias",
"criterion": "cardiac arrhythmias",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... myocarditis possibly related to prior cancer treatment",
"criterion": "myocarditis possibly related to prior cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; cardiomyopathy",
"criterion": "cardiomyopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... symptomatic heart failure",
"criterion": "symptomatic heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... asymptomatic reduced systolic function",
"criterion": "asymptomatic reduced systolic function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... acute coronary syndrome",
"criterion": "acute coronary syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... myocardial infarction",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... critical limb ischemia",
"criterion": "critical limb ischemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... cardiac arrhythmias",
"criterion": "cardiac arrhythmias",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Diagnosed with cardiotoxicity defined as; ... myocarditis possibly related to prior cancer treatment",
"criterion": "myocarditis possibly related to prior cancer treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Completed chemotherapy with no cardiotoxicity at least two years post treatment",
"criterions": [
{
"exact_snippets": "Completed chemotherapy",
"criterion": "chemotherapy completion",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "no cardiotoxicity",
"criterion": "cardiotoxicity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "at least two years post treatment",
"criterion": "time since treatment",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Completed chemotherapy",
"criterion": "chemotherapy completion",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "no cardiotoxicity",
"criterion": "cardiotoxicity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "at least two years post treatment",
"criterion": "time since treatment",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity",
"criterions": [
{
"exact_snippets": "Patients with cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "initiating systemic therapy",
"criterion": "systemic therapy",
"requirement": {
"requirement_type": "initiation",
"expected_value": true
}
},
{
"exact_snippets": "potentially cardiotoxic medications",
"criterion": "cardiotoxic medications",
"requirement": {
"requirement_type": "potential cardiotoxicity",
"expected_value": true
}
},
{
"exact_snippets": "chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "association with cardiac toxicity",
"expected_value": true
}
},
{
"exact_snippets": "immunotherapy",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "association with cardiac toxicity",
"expected_value": true
}
},
{
"exact_snippets": "targeted therapy",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "association with cardiac toxicity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients with cancer",
"criterion": "cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "initiating systemic therapy",
"criterion": "systemic therapy",
"requirement": {
"requirement_type": "initiation",
"expected_value": true
}
},
{
"exact_snippets": "potentially cardiotoxic medications",
"criterion": "cardiotoxic medications",
"requirement": {
"requirement_type": "potential cardiotoxicity",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "chemotherapy",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "association with cardiac toxicity",
"expected_value": true
}
},
{
"exact_snippets": "immunotherapy",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "association with cardiac toxicity",
"expected_value": true
}
},
{
"exact_snippets": "targeted therapy",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "association with cardiac toxicity",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* An understanding of the protocol and its requirements, risks, and discomforts",
"criterions": [
{
"exact_snippets": "An understanding of the protocol and its requirements, risks, and discomforts",
"criterion": "understanding of the protocol",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "An understanding of the protocol and its requirements, risks, and discomforts",
"criterion": "understanding of the protocol",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* The ability and willingness to sign an informed consent",
"criterions": [
{
"exact_snippets": "The ability ... to sign an informed consent",
"criterion": "ability to sign informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign an informed consent",
"criterion": "willingness to sign informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The ability ... to sign an informed consent",
"criterion": "ability to sign informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign an informed consent",
"criterion": "willingness to sign informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* One of the following:",
"criterions": []
},
"logical_structure": {
"or_criteria": []
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "- Inability on the part of the patient to understand the informed consent or be compliant with the protocol",
"criterions": [
{
"exact_snippets": "Inability on the part of the patient to understand the informed consent",
"criterion": "understanding of informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Inability on the part of the patient to ... be compliant with the protocol",
"criterion": "compliance with the protocol",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Inability on the part of the patient to understand the informed consent",
"criterion": "understanding of informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
},
{
"exact_snippets": "Inability on the part of the patient to ... be compliant with the protocol",
"criterion": "compliance with the protocol",
"requirement": {
"requirement_type": "ability",
"expected_value": false
}
}
]
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}
],
"failed_miscellaneous": []
}